PROLIS is continuously updated and new features are added to improve the functionalities of your laboratory. Audit trail of PROLIS is a very useful application which can be utilized for the following benefits:

  1. Routine Reviews & Approvals

A LIMS provides levels for data and user level access. A routine checkup of beyond the user profile actions can be checked and scrutinized using LIMS audit trail. Viewing audit trail for results review and approvals is a good way for a quality review. A sample approval can show if any results are added or deleted, edited or exceeded his assigned role. Any corrective action can be taken to maintain the transparency and improve the analysis process.

  • Investigate

If any result goes out of its limits an investigation is normally required. Any important changes such as clinical testing, toxicology reports or laboratory billing changes can be recorded in the audit trail and are readily available for view if an investigator needs to output data for analysis.

  • Periodic Review

A periodic review can be initiated using multiple ways.  An internal audit requirement, an office requirement or a customer complaint can be a source of a periodic review which may be helpful in improvement of the processes. An audit trail is very helpful during a periodic review as it enables the auditor to check each particular event with time and date stamp which can be used to assess whether the user actions were within the user right profiles and allowed procedures or not.

Auditing Process

PROLIS inserts a record into its DB a log is created, the process of auditing takes this log into the audit log at the time of its creation. Audit records are usually encrypted due to security reasons.

Validating any sample data and maintenance of an audit trail is a very important part of 21-CFR Part-11 compliance audit trails for computer systems controls and attendant documentation. This audit trail is basically the sequence of activities that have an effect on an action.

This audit trail normally contains the following data types:

  1. Event Type
  2. Action
  3. User
  4. Audit Time Stamp
  5. Reason
  6. Database Entries
  7. Child Records
  1. Event Type

PROLIS process type which generates an audit record e.g. Update Table, Log Sample, and Edit Tests are event types.

  • Action

An action which is performed by the database.

  • User

User ID user account who performed the action.

  • Audit Time Stamp

Date and time the action was performed.  If the system is a client/server implementation, the date and time of the local client is recorded.  If the system is a terminal service implementation, the date time stamp is displayed in GMT based on GMT offsets on the user account.

  • Reason

If an audit reason was provided at the time the action was performed, the value is displayed.  Otherwise, the phrase “No reason specified” is displayed by PROLIS.

  • Database Entries

PROLIS displays the key fields of the record updated.  If the action performed was an insert, all entered data is displayed for the record.  If the action performed was an update, only modified data is displayed.

  • Child Records

If any database record has inserted or updated child records, selecting the audit event for the parent record displays child record information in additional panes.